Acalabrutinib

Total global revenues of $1.5 billion and $5.3 billion for the fourth quarter and full year, increases of 33% and 40% from the prior-year periods Global BRUKINSA (zanubrutinib) revenues of $1.1 billion and $3.9 billion for the fourth quarter and full year, increases of 38% and 49% from the prior-year periods Diluted GAAP Earnings per American Depository Share (ADS) of $0.58 and $2.53 for the fourth quarter and full year; non-GAAP diluted Earnings per ADS of $1.95 and $8.09 for the fourth quarter and full year Full year 2026 total revenue guidance of $6.2 billion to $6.4 billion SAN CARLOS, Calif.--(BUSINESS WIRE)-- $ONC #BeOne -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the fourth quarter and full year 2025. “These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry’s deepest and most differentiated pipelines,” said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. “BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic reach, strong physician adoption, and unmatched long-term efficacy and safety data in CLL. At the same time, we are securing new indications and expanded reimbursement for TEVIMBRA across key markets worldwide. With our late-stage, foundational hematology assets nearing commercialization and a robust solid tumor portfolio delivering encouraging data, we are well positioned to extend our leadership and drive the next phase of sustainable global growth.” (Amounts in thousands of U.S. dollars full year GAAP amounts audited, all other amounts unaudited) Fourth Quarter Full Year 2025 2024 % Change 2025 2024 % Change Net product revenues $ 1,476,442 $ 1,118,035 32 % $ 5,282,061 $ 3,779,546 40 % Other revenue $ 21,728 $ 9,789 122 % $ 60,972 $ 30,695 99 % Total revenue $ 1,498,170 $ 1,127,824 33 % $ 5,343,033 $ 3,810,241 40 % GAAP income (loss) from operations $ 185,035 $ (79,425 ) 333 % $ 447,136 $ (568,199 ) 179 % Adjusted income from operations* $ 344,476 $ 78,603 338 % $ 1,099,962 $ 45,356 2325 % GAAP net income (loss) $ 66,502 $ (151,881 ) 144 % $ 286,933 $ (644,786 ) 145 % Adjusted net income (loss)* $ 224,979 $ 16,101 1297 % $ 917,601 $ (54,919 ) 1771 % GAAP basic earnings (loss) per ADS $ 0.60 $ (1.43 ) 142 % $ 2.63 $ (6.12 ) 143 % Adjusted basic earnings (loss) per ADS* $ 2.03 $ 0.15 1253 % $ 8.41 $ (0.52 ) 1717 % GAAP diluted earnings (loss) per ADS $ 0.58 $ (1.43 ) 141 % $ 2.53 $ (6.12 ) 141 % Adjusted diluted earnings (loss) per ADS* $ 1.95 $ 0.15 1200 % $ 8.09 $ (0.52 ) 1656 % Free Cash Flow* $ 379,825 $ (17,320 ) 2293 % $ 941,741 $ (633,294 ) 249 % * For an explanation of our use of non-GAAP financial measures refer to the “Note Regarding Use of Non-GAAP Financial Measures” section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release. Fourth Quarter and Full Year 2025 Financial Results Product Revenue , which represents 99% of total revenue , totaled $1.5 billion and $5.3 billion for the fourth quarter and full year of 2025, representing growth of 32% and 40%, compared to the prior-year periods. BRUKINSA: Global sales totaled $1.1 billion and $3.9 billion the fourth quarter and full year of 2025, representing growth of 38% and 49%, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $845 million and $2.8 billion in the fourth quarter and full year of 2025, representing growth of 37% and 45%, compared to the prior-year periods. TEVIMBRA (tislelizumab): Global sales totaled $182 million and $737 million, in the fourth quarter and full year of 2025, representing growth of 18% and 19%, compared to the prior-year periods. Amgen in-licensed products: Global sales totaled $112 million and $486 million for the fourth quarter and full year of 2025, representing growth of 11% and 33%, compared to prior-year periods. Gross Margin as a percentage of global product sales for the fourth quarter and full year of 2025 was 90.4% and 87.3%, compared to 85.6% and 84.3%, in the prior-year periods on a GAAP basis. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of global product sales increased to 90.7% and 87.8% for the fourth quarter and full year of 2025, compared to 87.4% and 85.5%, in the prior-year periods. Operating Expenses The following table summarizes operating expenses for the fourth quarter of 2025 and 2024: GAAP Non-GAAP (in thousands, except percentages) Q4 2025 Q4 2024 % Change Q4 2025 Q4 2024 % Change Research and development $ 615,423 $ 542,012 14 % $ 544,823 $ 474,874 15 % Selling, general and administrative $ 555,290 $ 504,677 10 % $ 471,468 $ 433,059 9 % Total operating expenses $ 1,170,713 $ 1,046,689 12 % $ 1,016,291 $ 907,933 12 % The following table summarizes operating expenses for the full year 2025 and 2024: GAAP Non-GAAP (in thousands, except percentages) FY 2025 FY 2024 % Change FY 2025 FY 2024 % Change Research and development $ 2,145,868 $ 1,953,295 10 % $ 1,855,979 $ 1,668,368 11 % Selling, general and administrative $ 2,081,489 $ 1,831,056 14 % $ 1,743,118 $ 1,549,864 12 % Total operating expenses $ 4,227,357 $ 3,784,351 12 % $ 3,599,097 $ 3,218,232 12 % Research and Development (R&D) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled nil and $0.7 million in the fourth quarter and full year of 2025, compared to $63 million and $114 million in the prior-year periods. Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year of 2025 compared to the prior-year periods on both a GAAP and adjusted basis. SG&A expenses as a percentage of product sales were 38% and 39% for the fourth quarter and full year of 2025, compared to 45% and 48% in the prior-year periods. Net Income/(Loss) and Basic/Diluted Earnings Per Share GAAP net income for the fourth quarter and full year of 2025 was $67 million and $287 million, an increase of $218 million and $932 million, over the prior-year periods, primarily attributable to revenue growth and improved operating leverage. Included within GAAP net income for full year 2025 were $76 million of equity investment impairment charges, $25 million of non-recurring tax expenses and $20 million of timing related tax expenses in certain jurisdictions, which were primarily incurred in the fourth quarter. For the fourth quarter of 2025, basic and diluted earnings per share were $0.05 and $0.04 per share and $0.60 and $0.58 per American Depositary Share (ADS), compared to basic loss of $0.11 per share and $1.43 per ADS in the prior-year period. For the full year of 2025, basic and diluted earnings per share were $0.20 and $0.19 per share and $2.63 and $2.53 per ADS, compared to basic loss of $0.47 per share and $6.12 per ADS in the prior-year period. Free Cash Flow for the fourth quarter of 2025 was $380 million, representing an increase of $397 million over the prior-year period. For the full year of 2025, free cash flow was $942 million, representing an increase of $1.6 billion over the prior-year period. For further details on BeOne’s 2025 Financial Statements, please see BeOne’s Annual Report on Form 10-K for fiscal year 2025 filed with the U.S. Securities and Exchange Commission. Full Year 2026 Guidance BeOne’s financial guidance is summarized below: FY 2026 1 Total revenue $6.2 - $6.4 billion GAAP gross margin % High-80% range GAAP operating expenses 2 (combined R&D and SG&A) $4.7 - $4.9 billion GAAP operating income 2 $700 - $800 million Non-GAAP operating income 2,3 $1.4 - $1.5 billion 1 Assumes January 1, 2026 foreign exchange rates. 2 Does not assume any potential new, material business development activity or unusual/non-recurring items. 3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth. BeOne’s total revenue guidance for full year 2026 of $6.2 billion to $6.4 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. The Company is providing the following additional guidance on items impacting net income and earnings per ADS: Other income (expense) : estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement. Income tax outlook : earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. Diluted ADS outstanding : the Company expects diluted ADSs outstanding of approximately 118 million. Fourth Quarter Business Highlights Core Marketed Products BRUKINSA (zanubrutinib) Presented 6-year landmark results from the Phase 3 SEQUOIA trial and long-term results from the Phase 3 ALPINE trial at the American Society of Hematology (ASH) Annual Meeting, confirming sustained benefit for the treatment of adult patients with treatment-naïve (TN) and relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), respectively. Sonrotoclax (BCL2 inhibitor) Received first global approvals in China for the treatment of adult patients with: R/R mantle cell lymphoma (MCL) who have received at least two systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor; and R/R CLL/SLL who have previously received at least one systemic therapy, including a BTK inhibitor. Granted U.S. Food and Drug Administration (FDA) priority review for the treatment of adult patients with R/R MCL. Submitted Marketing Authorization Application in the European Union for the treatment of adult patients with R/R MCL. Enrolled first subject in Phase 3 trial in combination with BRUKINSA as a fixed-duration regimen versus acalabrutinib plus venetoclax for the treatment of adult patients with TN CLL. TEVIMBRA (tislelizumab) Presented full results in partnership with Jazz Pharmaceuticals and Zymeworks from the HERIZON-GEA-01 trial in combination with ZIIHERA (zanidatamab) and chemotherapy, demonstrating statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy for the first-line treatment of adult patients with HER2-positive gastroesophageal adenocarcinoma (GEA). Select Clinical-Stage Programs Hematology BGB-16673 (BTK chimeric degradation activation compound (CDAC)): Presented results at ASH from the Phase 1 CaDAnCe-101 trial for the treatment of adult patients with R/R CLL. Breast and Gynecologic Cancers BG-75202 (KAT6A/B inhibitor): Initiated first in human study. BG-75908 (CDK2 CDAC): Initiated first in human study. Lung Cancer BG-C0902 (EGFRxMETxMET antibody-drug conjugate): Initiated first in human study. Gastrointestinal Cancers BGB-B2033 (GPC3x41BB bispecific antibody): Granted FDA Fast Track Designation for the treatment of adult patients with hepatocellular carcinoma who experience disease progression on or after post-systemic therapy. Anticipated R&D Milestones Programs Milestones Timing BRUKINSA • Phase 3 MANGROVE trial interim analysis in combination with rituximab versus bendustamine plus rituximab for the treatment of adult patients with first-line MCL. 1H 2026 TEVIMBRA • Supplemental Biologics License Application submissions in U.S. and China for the treatment of adult patients with first-line HER2-positive GEA in combination with zanidatamab. 1H 2026 • Japan regulatory action for the treatment of adult patients with first-line gastric cancer. 2H 2026 Hematology • Sonrotoclax (BCL2 inhibitor): ◦ FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL. 1H 2026 ◦ Phase 3 trial initiation for the treatment of adult patients with R/R multiple myeloma t(11;14). 2H 2026 • BGB-16673 (BTK CDAC): ◦ Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL. 2H 2026 Breast/Gynecologic Cancers • BGB-43395 (CDK4 inhibitor): 1H 2026 ◦ Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer. Gastrointestinal Cancers • BGB-B2033 (GPC3x41BB bispecific antibody): 2H 2026 ◦ Potentially registrational Phase 2 trial initiation. Inflammation and Immunology • BGB-45035 (IRAK4 CDAC): ◦ Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis. 2H 2026 • BGB-16673 (BTK CDAC): ◦ Phase 1b trial data readout for the treatment of adult patients with moderate to severe chronic spontaneous urticaria. 1H 2026 BeOne’s Earnings Results Webcast The Company’s earnings conference call for the fourth quarter and full year 2025 will be broadcast via webcast at 8:00 a.m. ET on Thursday, February 26, 2026, and will be accessible through the Investors section of BeOne’s website at . Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available. About BeOne BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: potential commercialization of BeOne’s late-stage hematology assets; BeOne’s next phase of global growth; BeOne’s future revenue, gross margin percentage, operating expenses, operating income, other income or expense, income tax and diluted ADS outstanding; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Condensed Consolidated Statements of Operations (U.S. GAAP) (Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data) Fourth Quarter Full Year 2025 2024 2025 2024 (unaudited) (audited) Revenue Product revenue, net $ 1,476,442 $ 1,118,035 $ 5,282,061 $ 3,779,546 Other revenue 21,728 9,789 60,972 30,695 Total revenues 1,498,170 1,127,824 5,343,033 3,810,241 Cost of sales – products 142,422 160,560 668,540 594,089 Gross profit 1,355,748 967,264 4,674,493 3,216,152 Operating expenses Research and development 615,423 542,012 2,145,868 1,953,295 Selling, general and administrative 555,290 504,677 2,081,489 1,831,056 Total operating expenses 1,170,713 1,046,689 4,227,357 3,784,351 Income (loss) from operations 185,035 (79,425 ) 447,136 (568,199 ) Interest income 26,770 14,707 70,505 69,641 Interest expense (26,873 ) (6,899 ) (58,234 ) (21,805 ) Other expense, net (35,691 ) (13,734 ) (42,553 ) (12,638 ) Income (loss) before income taxes 149,241 (85,351 ) 416,854 (533,001 ) Income tax expense 82,739 66,530 129,921 111,785 Net income (loss) 66,502 (151,881 ) 286,933 (644,786 ) Earnings (loss) per share Basic $ 0.05 $ (0.11 ) $ 0.20 $ (0.47 ) Diluted $ 0.04 $ (0.11 ) $ 0.19 $ (0.47 ) Weighted-average shares outstanding—basic 1,439,485,461 1,381,378,234 1,417,803,727 1,368,746,793 Weighted-average shares outstanding—diluted 1,499,900,248 1,381,378,234 1,474,829,908 1,368,746,793 Earnings (loss) per American Depositary Share (“ADS”) Basic $ 0.60 $ (1.43 ) $ 2.63 $ (6.12 ) Diluted $ 0.58 $ (1.43 ) $ 2.53 $ (6.12 ) Weighted-average ADSs outstanding—basic 110,729,651 106,259,864 109,061,825 105,288,215 Weighted-average ADSs outstanding—diluted 115,376,942 106,259,864 113,448,454 105,288,215 Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of December 31, 2025 2024 (audited) Assets: Cash, cash equivalents and restricted cash $ 4,609,647 $ 2,638,747 Accounts receivable, net 865,080 676,278 Inventories, net 608,227 494,986 Property, plant and equipment, net 1,641,678 1,578,423 Total assets $ 8,188,573 $ 5,920,910 Liabilities and equity: Accounts payable $ 479,035 $ 404,997 Accrued expenses and other payables 1,109,120 803,713 Royalty financing liability 906,956 — R&D cost share liability 64,345 165,440 Debt 1,019,206 1,018,013 Total liabilities 3,827,379 2,588,688 Total equity $ 4,361,194 $ 3,332,222 Select Condensed Consolidated Statements of Cash Flows (U.S. GAAP) (Amounts in thousands of U.S. Dollars) Fourth Quarter Full Year 2025 2024 2025 2024 (unaudited) (audited) Cash, cash equivalents and restricted cash at beginning of period $ 4,110,542 $ 2,713,428 $ 2,638,747 $ 3,185,984 Net cash provided by (used in) operating activities 417,347 75,160 1,127,580 (140,631 ) Net cash used in investing activities (38,335 ) (93,605 ) (276,155 ) (548,350 ) Net cash provided by (used in) financing activities 96,931 (4,523 ) 1,059,451 193,449 Net effect of foreign exchange rate changes 23,162 (51,713 ) 60,024 (51,705 ) Net increase (decrease) in cash, cash equivalents and restricted cash 499,105 (74,681 ) 1,970,900 (547,237 ) Cash, cash equivalents and restricted cash at end of period $ 4,609,647 $ 2,638,747 $ 4,609,647 $ 2,638,747 Note Regarding Use of Non-GAAP Financial Measures BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES (Amounts in thousands of U.S. Dollars) (unaudited) Fourth Quarter Full Year 2025 2024 2025 2024 Reconciliation of GAAP to adjusted cost of sales - products: GAAP cost of sales – products $ 142,422 $ 160,560 $ 668,540 $ 594,089 Less: Depreciation 3,474 18,089 13,669 42,707 Less: Amortization of intangibles 1,545 1,183 10,004 4,729 Less: Other — — 893 — Adjusted cost of sales – products $ 137,403 $ 141,288 $ 643,974 $ 546,653 Reconciliation of GAAP to adjusted research and development: GAAP research and development $ 615,423 $ 542,012 $ 2,145,868 $ 1,953,295 Less: Share-based compensation expenses 52,442 44,992 217,440 186,113 Less: Depreciation 18,158 22,146 72,449 98,814 Adjusted research and development $ 544,823 $ 474,874 $ 1,855,979 $ 1,668,368 Reconciliation of GAAP to adjusted selling, general and administrative: GAAP selling, general and administrative $ 555,290 $ 504,677 $ 2,081,489 $ 1,831,056 Less: Share-based compensation expenses 71,015 62,790 292,807 255,680 Less: Depreciation 12,785 8,811 45,497 25,417 Less: Amortization of intangibles 22 17 67 95 Adjusted selling, general and administrative $ 471,468 $ 433,059 $ 1,743,118 $ 1,549,864 Reconciliation of GAAP to adjusted operating expenses GAAP operating expenses $ 1,170,713 $ 1,046,689 $ 4,227,357 $ 3,784,351 Less: Share-based compensation expenses 123,457 107,782 510,247 441,793 Less: Depreciation 30,943 30,957 117,946 124,231 Less: Amortization of intangibles 22 17 67 95 Adjusted operating expenses $ 1,016,291 $ 907,933 $ 3,599,097 $ 3,218,232 Reconciliation of GAAP to adjusted income (loss) from operations: GAAP income (loss) from operations $ 185,035 $ (79,425 ) $ 447,136 $ (568,199 ) Plus: Share-based compensation expenses 123,457 107,782 510,247 441,793 Plus: Depreciation 34,417 49,046 131,615 166,938 Plus: Amortization of intangibles 1,567 1,200 10,071 4,824 Plus: Other — — 893 — Adjusted income (loss) from operations $ 344,476 $ 78,603 $ 1,099,962 $ 45,356 Reconciliation of GAAP to adjusted net income (loss): GAAP net income (loss) $ 66,502 $ (151,881 ) $ 286,933 $ (644,786 ) Plus: Share-based compensation expenses 123,457 107,782 510,247 441,793 Plus: Depreciation 34,417 49,046 131,615 166,938 Plus: Amortization of intangibles 1,567 1,200 10,071 4,824 Plus: Other — — 893 — Plus: Impairment of equity investments 41,410 6,838 75,626 6,838 Plus: Discrete tax items 34,441 15,232 24,778 18,597 Plus: Income tax effect of non-GAAP adjustments (76,815 ) (12,116 ) (122,562 ) (49,123 ) Adjusted net income (loss) $ 224,979 $ 16,101 $ 917,601 $ (54,919 ) Reconciliation of GAAP to adjusted EPS - basic GAAP earnings (loss) per share - basic $ 0.05 $ (0.11 ) $ 0.20 $ (0.47 ) Plus: Share-based compensation expenses 0.09 0.08 0.36 0.32 Plus: Depreciation 0.02 0.04 0.09 0.12 Plus: Amortization of intangibles 0.00 0.00 0.01 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.03 0.00 0.05 0.00 Plus: Discrete tax items 0.02 0.01 0.02 0.01 Plus: Income tax effect of non-GAAP adjustments (0.05 ) (0.01 ) (0.09 ) (0.04 ) Adjusted earnings (loss) per share - basic $ 0.16 $ 0.01 $ 0.65 $ (0.04 ) Reconciliation of GAAP to adjusted EPS - diluted GAAP earnings (loss) per share - diluted $ 0.04 $ (0.11 ) $ 0.19 $ (0.47 ) Plus: Share-based compensation expenses 0.08 0.08 0.35 0.32 Plus: Depreciation 0.02 0.03 0.09 0.12 Plus: Amortization of intangibles 0.00 0.00 0.01 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.03 0.00 0.05 0.00 Plus: Discrete tax items 0.02 0.01 0.02 0.01 Plus: Income tax effect of non-GAAP adjustments (0.05 ) (0.01 ) (0.08 ) (0.04 ) Adjusted earnings (loss) per share - diluted $ 0.15 $ 0.01 $ 0.62 $ (0.04 ) Reconciliation of GAAP to adjusted earnings (loss) per ADS - basic GAAP earnings (loss) per ADS - basic $ 0.60 $ (1.43 ) $ 2.63 $ (6.12 ) Plus: Share-based compensation expenses 1.11 1.01 4.68 4.20 Plus: Depreciation 0.31 0.46 1.21 1.59 Plus: Amortization of intangibles 0.01 0.01 0.09 0.05 Plus: Other 0.00 0.00 0.01 0.00 Plus: Impairment of equity investments 0.37 0.06 0.69 0.06 Plus: Discrete tax items 0.31 0.14 0.23 0.18 Plus: Income tax effect of non-GAAP adjustments (0.69 ) (0.11 ) (1.12 ) (0.47 ) Adjusted earnings (loss) per ADS - basic $ 2.03 $ 0.15 $ 8.41 $ (0.52 ) Reconciliation of GAAP to adjusted earnings (loss) per ADS - diluted GAAP earnings (loss) per ADS - diluted 1 $ 0.58 $ (1.39 ) $ 2.53 $ (6.12 ) Plus: Share-based compensation expenses 1.07 0.98 4.50 4.20 Plus: Depreciation 0.30 0.45 1.16 1.59 Plus: Amortization of intangibles 0.01 0.01 0.09 0.05 Plus: Other 0.00 0.00 0.01 0.00 Plus: Impairment of equity investments 0.36 0.06 0.67 0.06 Plus: Discrete tax items 0.30 0.14 0.22 0.18 Plus: Income tax effect of non-GAAP adjustments (0.67 ) (0.11 ) (1.08 ) (0.47 ) Adjusted earnings (loss) per ADS - diluted $ 1.95 $ 0.15 $ 8.09 $ (0.52 ) Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beonemed.com Media Contact Kyle Blankenship +1 667-351-5176 media@beonemed.com Read full story here

LUND, SE / ACCESS Newswire / February 26, 2026 / BioInvent International (STO:BINV) - "During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier programs to maximize the probability of success and near-term value creation."- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (R) Promising early Phase 2a monotherapy data for the company's lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025 (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin's Lymphoma (NHL) presented at ASH 2025 Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and Calquence® for the treatment of NHL BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025 Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer FDA Fast Track Designation received for BI-1808 for the treatment of CTCL BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025 • Net sales SEK 3.0 (21.4) million • Profit/loss after tax SEK -125.8 (-116.9) million • Profit/loss after tax per share before and after dilution SEK -1.91 (-1.78) • Cash flow from operating activities SEK-90.6 (-98.3) million January - December 2025 • Net sales SEK 226.5 (44.7) million • Profit/loss after tax SEK -332.9 (-429.4) million • Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53) • Cash flow from operating activities SEK -247.8 (-380.5) million • Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company's website under Financial reports . INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025 BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English. When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at . If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference. . The conference call will be made available on the company website after the call. About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T ™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . For further information, please contact: Cecilia Hofvander, VP Investor Relations Phone: +46 (0)46 286 85 50 Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ) Co. Reg. No.: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 Attachments BioInvent Q4, 2025 EN Final SOURCE: BioInvent International View the original press release on ACCESS Newswire